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[Recalled] SafeStar 90 Plus Filter. Bidirectionally breathing system filter. — Reports of slow increase of CO2-curve when gas sample is taken from the gas sam… | FDA 2025-06-16

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductSafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Brand / manufacturerDraeger, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2158-2025
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date16 June 2025
EAN / barcode04048675665762

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Draeger, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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